ADVM Adverum Biotechnologies Inc.

20.82
-0.26  -1%
Previous Close 21.08
Open 21.44
52 Week Low 4.96
52 Week High 26.98
Market Cap $1,671,753,559
Shares 80,295,560
Float 72,656,271
Enterprise Value $1,427,342,404
Volume 486,269
Av. Daily Volume 1,411,227
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Upcoming Catalysts

Drug Stage Catalyst Date
ADVM-022 (OPTIC)
Wet age-related macular degeneration (Wet-AMD)
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
ADVM-022 - INFINITY
Diabetic macular edema
Phase 2
Phase 2
Phase 2 trial initiation announced May 28, 2020.
ADVM-043
Alpha-1 Antitrypsin (A1AT) Deficiency
Phase 1/2
Phase 1/2
Development to be discontinued - noted November 1, 2018.
AVA-101
Wet age-related macular degeneration (Wet-AMD)
Phase 2a
Phase 2a
Phase 2a negative data released June 2015 (met primary endpoint but increase in retinal thickness). As a result Phase 2b development will not proceed.

Latest News

  1. -- Plans underway to begin expansion of manufacturing capabilities --

    REDWOOD CITY, Calif., June 25, 2020 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced that Heikki Jouttijärvi joined the company as vice president, manufacturing. In this newly created position, Mr. Jouttijärvi will be responsible for leading the manufacturing and supply chain strategy and operations. This position will report into Adverum's chief technology officer, Angela Thedinga.

    "We are excited to have Heikki join our team and partner with Angela to recruit additional professionals to further strengthen the extensive manufacturing experience…

    -- Plans underway to begin expansion of manufacturing capabilities --

    REDWOOD CITY, Calif., June 25, 2020 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced that Heikki Jouttijärvi joined the company as vice president, manufacturing. In this newly created position, Mr. Jouttijärvi will be responsible for leading the manufacturing and supply chain strategy and operations. This position will report into Adverum's chief technology officer, Angela Thedinga.

    "We are excited to have Heikki join our team and partner with Angela to recruit additional professionals to further strengthen the extensive manufacturing experience of our team," said Leone Patterson, president of Adverum. "Heikki brings extensive global expertise in the pharmaceutical industry which includes both external and internal manufacturing as well as sourcing, supply chain, and logistics. He also brings valuable experience in manufacturing several sterile ophthalmic products. As we continue to advance ADVM-022 in our OPTIC and INFINITY clinical trials and plan for later-stage studies in these programs, Heikki's experience will be instrumental to our planned growth and expansion of our manufacturing capabilities."

    Mr. Jouttijärvi has more than 25 years of experience in the pharmaceutical industry which includes global sourcing, supply chain, and external and internal manufacturing between Europe, United States and Asia. Prior to joining Adverum, Mr. Jouttijärvi was vice president, technical operations at Menlo Therapeutics, Inc. From 1999-2017, Mr. Jouttijärvi held various roles of increasing responsibility at Santen Pharmaceutical Company, Ltd., and its subsidiaries, most recently serving in the role of vice president, head of global external manufacturing and sourcing. He began his career as a pharmacist. Mr. Jouttijärvi holds a Master of Science degree in Pharmaceutical Sciences with a major in Pharmaceutical Analytical Chemistry from the University of Helsinki, Finland.        

    On June 22, the company granted Mr. Jouttijärvi a stock option to purchase 100,000 shares of Adverum's common stock pursuant to the inducement grant exception under Nasdaq Rule 5635(c)(4), as an inducement that is material to his entering into employment with Adverum. The option has a per share exercise price equal to the closing sales price of Adverum's common stock on the Nasdaq Stock Market on the grant date, and will vest over four years, subject to his continued service with Adverum.

    About Adverum Biotechnologies

    Adverum Biotechnologies (NASDAQ:ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases. Adverum is advancing the clinical development of its novel gene therapy candidate, ADVM-022, as a one-time, intravitreal injection for the treatment of patients with wet age-related macular degeneration and diabetic macular edema. For more information, please visit www.adverum.com.

    Forward-looking Statements

    Statements contained in this press release regarding the events or results that may occur in the future are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include but are not limited to statements regarding: Adverum's advancements of current clinical trials, and its plans for later-stage clinical trials and growth and expansion of its manufacturing capabilities; and Adverum's expectations as to the benefits it expects from the addition of Mr. Jouttijärvi.  Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include risks inherent to, without limitation: Adverum's novel technology, which makes it difficult to predict the time and cost of product candidate development and obtaining regulatory approval; the results of early clinical trials not always being predictive of future results; the potential for future complications or side effects in connection with use of ADVM-022; obtaining regulatory approval for gene therapy product candidates; enrolling patients in clinical trials; reliance on third parties for conducting the OPTIC and INFINITY trials and vector production; the effects of the COVID-19 pandemic on the company's operations and on the company's ongoing clinical trials; and ability to fund operations through completion of the OPTIC and INFINITY trials and thereafter. Risks and uncertainties facing Adverum are described more fully in Adverum's Form 10-Q filed with the SEC on May 28, 2020 under the heading "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. Adverum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor and Media Inquiries:

    Investors:

    Myesha Lacy

    Adverum Biotechnologies, Inc.



    1-650-304-3892

    Media:

    Cherilyn Cecchini, M.D.

    LifeSci Communications



    1-646-876-5196

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  2. -- Laurent Fischer, M.D. joins as CEO --
    -- Leone Patterson will continue to serve as president --

    REDWOOD CITY, Calif., June 15, 2020 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced that Laurent Fischer, M.D. has joined the company as its chief executive officer and a member of the board of directors. Leone Patterson, who has served for four years in executive leadership roles at Adverum, most recently as the company's CEO, will continue to serve as the company's president.   

    "We are delighted to welcome an experienced industry leader of Laurent's caliber to our team at Adverum," said Patrick Machado, J.D., Board…

    -- Laurent Fischer, M.D. joins as CEO --

    -- Leone Patterson will continue to serve as president --

    REDWOOD CITY, Calif., June 15, 2020 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced that Laurent Fischer, M.D. has joined the company as its chief executive officer and a member of the board of directors. Leone Patterson, who has served for four years in executive leadership roles at Adverum, most recently as the company's CEO, will continue to serve as the company's president.   

    "We are delighted to welcome an experienced industry leader of Laurent's caliber to our team at Adverum," said Patrick Machado, J.D., Board Chair of Adverum. "The skills that Laurent brings to our company as a physician and experienced public company CEO will be invaluable additions to our existing executive team, and set us up well for future success as we enter the next phase of our growth."

    Mr. Machado continued, "We are also equally thrilled to be able to retain Leone's substantial expertise in her continued role as president. The accomplishments Adverum has achieved during Leone's tenure as CEO have been formidable, including generating strongly positive clinical data in the OPTIC Phase 1 study evaluating ADVM-022 for the treatment of wet age-related macular degeneration (AMD), recruiting our entire executive team, and driving market value significantly. Adverum has a substantial opportunity to meaningfully elevate the standard of care for patients at risk of losing their vision. The board is convinced that Laurent, Leone and our existing executive team bring the right combination of experience and talent to optimize this unique opportunity for patients, physicians and all stakeholders."

    Dr. Fischer added, "I am delighted to join the team at Adverum at this pivotal stage of the company's growth. This high-performing team has done a phenomenal job executing on developing ADVM-022, a potential one-time treatment for wet AMD and diabetic macular edema (DME). I believe Adverum can significantly disrupt the anti-VEGF market with ADVM-022, offering a more patient-centric treatment approach to preserve vision in patients with serious ocular diseases. During my career, I have developed and commercialized novel, first-in-class drugs in multiple therapeutic categories with significant unmet medical need. I look forward to providing my strategic experience as we continue the course of making ADVM-022 available to patients."

    Ms. Patterson commented, "It has been exciting to lead Adverum's transformation and the advancement of ADVM-022 from a pre-clinical to a clinical-stage asset, targeting two large ocular disease indications. I am grateful to have led our industry-leading team with a shared commitment to develop a single intravitreal injection gene therapy for patients with wet AMD and DME. I look forward to partnering with Laurent in my role as president, leading the company's key operational functions as we head towards later-stage development."

    Dr. Fischer has more than 20 years of drug development and commercialization experience in the biopharmaceutical industry. Most recently, Dr. Fischer was senior vice president and head of the Liver Therapeutic Area at Allergan, PLC. Previously, he served as chairman and chief executive officer of Tobira Therapeutics until its acquisition by Allergan in November 2016. Previously, he served as chairman and chief executive officer of Jennerex, Inc., until its acquisition by SillaJen Biotherapeutics, Inc. Prior to Jennerex, he was co-founder, president and chief executive officer of Ocera Therapeutics and president and chief executive officer of Auxeris Therapeutics, Inc. Over the span of his career, Dr. Fischer has held roles of increasing responsibility at several companies, including RXCentric, Inc. (now part of Allscripts Healthcare Solutions, Inc.), MedVantx Inc., Dupont Pharmaceuticals, Dupont-Merck, and F. Hoffmann-La Roche.

    Dr. Fischer received his undergraduate degree from the University of Geneva and his medical degree from the Geneva Medical School, Switzerland.

    Dr. Fischer currently serves as chairman of the board of CTI Biopharma, as director at Mirum Pharmaceuticals, Inc. and Lycia Therapeutics, and as senior advisor on the Life Sciences Team at Frazier Healthcare Partners. 

    Today, the company has granted Dr. Fischer  a stock option to purchase 1,200,000 shares of Adverum's common stock pursuant to the inducement grant exception under Nasdaq Rule 5635(c)(4), as an inducement that is material to his entering into employment with Adverum. The option has a per share exercise price equal to the closing sales price of Adverum's common stock on the Nasdaq Stock Market on the grant date, and will vest over four years, subject to his continued service with Adverum.

    About Adverum Biotechnologies

    Adverum Biotechnologies (NASDAQ:ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases. Adverum is advancing the clinical development of its novel gene therapy candidate, ADVM-022, as a one-time, intravitreal injection for the treatment of patients with wet age-related macular degeneration and diabetic macular edema. For more information, please visit www.adverum.com.

    Forward-looking Statements

    Statements contained in this press release regarding the events or results that may occur in the future are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include but are not limited to statements regarding: the potential for ADVM-022 in treating patients with wet AMD and DME; and Adverum's expectations as to the benefits it expects from the management transition.  Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include risks inherent to, without limitation: Adverum's novel technology, which makes it difficult to predict the time and cost of product candidate development and obtaining regulatory approval; the results of early clinical trials not always being predictive of future results; the potential for future complications or side effects in connection with use of ADVM-022; obtaining regulatory approval for gene therapy product candidates; enrolling patients in clinical trials; reliance on third parties for conducting the OPTIC and INFINITY trials and vector production; the effects of the COVID-19 pandemic on the company's operations and on the company's ongoing clinical trials; and ability to fund operations through completion of the OPTIC and INFINITY trials and thereafter. Risks and uncertainties facing Adverum are described more fully in Adverum's Form 10-Q filed with the SEC on May 28, 2020 under the heading "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. Adverum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

     

    Investor and Media Inquiries:
    
    Investors:
    Myesha Lacy
    Adverum Biotechnologies, Inc.
    
    1-650-304-3892
    
    Media:
    Cherilyn Cecchini, M.D.
    LifeSci Communications
    
    1-646-876-5196

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  3. REDWOOD CITY, Calif., June 04, 2020 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced that the company will present at the Goldman Sachs 41st Annual Global Healthcare Conference on Thursday, June 11, 2020 at 3:50 pm EDT.

    A live webcast will be accessible under Events and Presentations in the Investors section of the company's website. The archived webcast will be available on the Adverum website following the presentation for 30 days.

    About Adverum Biotechnologies
    Adverum Biotechnologies (NASDAQ:ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases. Adverum…

    REDWOOD CITY, Calif., June 04, 2020 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced that the company will present at the Goldman Sachs 41st Annual Global Healthcare Conference on Thursday, June 11, 2020 at 3:50 pm EDT.

    A live webcast will be accessible under Events and Presentations in the Investors section of the company's website. The archived webcast will be available on the Adverum website following the presentation for 30 days.

    About Adverum Biotechnologies
    Adverum Biotechnologies (NASDAQ:ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases. Adverum is advancing the clinical development of its novel gene therapy candidate, ADVM-022, as a one-time, intravitreal injection for the treatment of patients with wet age-related macular degeneration and diabetic macular edema. For more information, please visit www.adverum.com.

    Investor and Media Inquiries:

    Investors:
    Myesha Lacy
    Adverum Biotechnologies, Inc.

    1-650-304-3892

    Media:
    Cherilyn Cecchini, M.D.
    LifeSci Communications

    1-646-876-5196

    Primary Logo

    View Full Article Hide Full Article
  4. -- INFINITY is a randomized, active comparator-controlled trial --

    -- INFINITY trial initiated for patients with diabetic macular edema, the most common cause of vision loss in people with diabetic retinopathy --

    -- Positive interim clinical data recently presented for ADVM-022 in OPTIC Phase 1 trial for wet AMD; data from all four cohorts expected to be presented by year-end --

    -- Company to host conference call today at 1:30 pm PDT / 4:30 pm EDT --

    REDWOOD CITY, Calif., May 28, 2020 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced the initiation of INFINITY, a Phase 2,  multi-center, randomized, double-masked…

    -- INFINITY is a randomized, active comparator-controlled trial --

    -- INFINITY trial initiated for patients with diabetic macular edema, the most common cause of vision loss in people with diabetic retinopathy --

    -- Positive interim clinical data recently presented for ADVM-022 in OPTIC Phase 1 trial for wet AMD; data from all four cohorts expected to be presented by year-end --

    -- Company to host conference call today at 1:30 pm PDT / 4:30 pm EDT --

    REDWOOD CITY, Calif., May 28, 2020 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced the initiation of INFINITY, a Phase 2,  multi-center, randomized, double-masked, active comparator-controlled trial to assess a single intravitreal (IVT) injection of ADVM-022 in patients with diabetic macular edema (DME). The company also reported financial results for the first quarter ended March 31, 2020 and provided a corporate update.

    The INFINITY trial will enroll approximately 33 patients and is designed to demonstrate superior control of disease activity following a single IVT injection of ADVM-022 compared to a single aflibercept injection, as measured by time to worsening of DME disease activity. Additional objectives include assessments of treatment burden, visual acuity, retinal anatomy and safety outcomes.

    Participants in this double-masked trial will be randomized to one of three arms for their study eye treatment:

    • Arm 1 will receive the higher dose of ADVM-022 at 6x1011 vg.
    • Arm 2 will receive the lower dose of ADVM-022 at 2x1011 vg.
    • Arm 3 will receive aflibercept at a dose of 2 mg.

    "I'm thankful for the strong commitment and resilience our employees have exhibited towards advancing our pipeline despite the challenges of COVID 19," said Leone Patterson, president and chief executive officer, Adverum Biotechnologies. "We continue to execute on our goal to develop and commercialize our novel gene therapy candidate ADVM-022 as a potential one-time treatment for patients with wet age-related macular degeneration (AMD) and DME, the two largest indications for anti-VEGF treatment. With the recent approval of our Investigational New Drug application for ADVM-022, we have initiated INFINITY in DME, a high-need subgroup of patients within the larger DR population. Additionally, we look forward to presenting data from all four cohorts of the OPTIC Phase 1 trial for ADVM-022 in wet AMD by the end of this year."

    Aaron Osborne, MBBS, chief medical officer of Adverum Biotechnologies stated, "Over 30 million people are impacted by diabetes in the United States. DME affects approximately 5% of people with diabetes and is the most common cause of vision loss in people with diabetic retinopathy (DR). We believe that the exciting data seen to date for ADVM-022 in the ongoing OPTIC trial in wet AMD highlight this therapy's transformative potential to deliver long-term control of serious retinal vascular diseases, including DME. INFINITY has been designed to provide robust, controlled data on ADVM-022 in DME and will be conducted at trial sites across the United States."

    Recent Progress

    • The U.S. Food and Drug Administration (FDA) approved Adverum's IND application for ADVM-022 (AAV.7m8-aflibercept) for the treatment of DR. The company has initiated INFINITY, a Phase 2, multi-center, randomized, double-masked, active comparator-controlled trial, to assess a single IVT injection of ADVM-022 in patients with DME, the most common cause of vision loss in patients with DR. INFINITY will enroll approximately 33 patients and is designed to demonstrate superior control of disease activity following a single IVT injection of ADVM-022 compared to a single aflibercept injection, as measured by time to worsening of DME disease activity. Additional objectives include assessments of treatment burden, visual acuity, retinal anatomy and safety outcomes.
       
    • In early May, positive interim clinical data were presented from Cohorts 1-3 of the OPTIC Phase 1 dose-ranging clinical trial of ADVM-022 in patients requiring frequent anti-VEGF injections for wet age-related macular degeneration (wet AMD). Following a single IVT injection, ADVM-022 showed long-term durability beyond 1 year with zero rescue injections in Cohort 1. Additionally, early evidence from Cohort 3 suggested that a 6-week prophylactic regimen of steroid eye drops results in fewer adverse events and less inflammation, compared to a 13-day prophylactic regimen of oral steroids as used in Cohorts 1 and 2.
      °      Began dosing patients in April in Cohort 4 (n=9, dose 6 x 1011 vg and a 6-week prophylactic regimen of steroid eye drops).
      °      Data from all four cohorts expected to be presented by year-end.
       
    • Scott Whitcup, M.D. was appointed to Adverum's Board of Directors. Dr. Whitcup has over 20 years of biopharmaceutical industry experience, with extensive expertise in drug development and regulatory approvals, including products for the treatment of patients with ocular disease.
       
    • The company raised approximately $140.9 million in net proceeds from an underwritten public offering in February 2020.

    COVID-19
    In March 2020, the San Francisco Bay Area of California, where Adverum has its corporate headquarters, mandated a Shelter-in-Place Executive Order in response to the World Health Organization declaring a pandemic related to coronavirus (COVID-19). The company's primary focus is on the health and safety of its employees, patients, and healthcare providers. In mid-March, the company implemented a number of actions, including a work-from-home policy for employees whose jobs have not required them to be on-site. The company has maintained certain essential in-person laboratory functions in order to advance key research and development initiatives supported by the implementation of updated onsite procedures. The company believes these measures and others have allowed it to mitigate, but not eliminate, the effects on and risks of on-site operations posed by the COVID-19 pandemic.

    In the OPTIC Phase 1 trial, patients with wet AMD are in high-risk categories for COVID-19 complications based on age, comorbidities, or both. The company is working closely with clinical trial sites to monitor and attempt to minimize the potential negative impacts of the evolving COVID-19 outbreak on patient safety, patient enrollment, continued participation of patients already enrolled in the company's clinical studies, protocol compliance, data quality, and overall study integrity. Despite these efforts, the company continues to assess whether the COVID-19 pandemic will significantly impact trial enrollment or completion of the current or planned clinical studies. Additionally, although the company has sufficient drug supply for its current clinical trials, it is working with its product supply partners to implement measures where possible to attempt to mitigate the COVID-19 pandemic's effects on and risks to its future clinical supply needs and long-term timelines, which may result in additional expenses.

    Financial Results for the Three Months Ended March 31, 2020

    • Cash, cash equivalents and short-term investments were $297.1 million as of March 31, 2020, compared to $166.0 million as of December 31, 2019. In February 2020, Adverum raised approximately $140.9 million in net proceeds from an underwritten public offering. Adverum expects this quarter-end cash position to fund operations into 2022.
    • Research and development expenses were $14.8 million for the three months ended March 31, 2020, compared to $10.1 million for the same period in 2019. Research and development expenses increased primarily due to higher material production costs, personnel-associated costs, and increased facilities costs related to the company's new facility.
    • General and administrative expenses were $9.0 million for the three months ended March 31, 2020, compared to $5.6 million for the same period in 2019. General and administrative expenses increased primarily due to higher personnel-associated costs, including stock-based compensation expenses, and professional service and consultant expenses.
    • Net loss was $22.9 million, or $0.31 per basic and diluted share, for the three months ended March 31, 2020, compared to $14.5 million, or $0.23 per basic and diluted share, for the same period in 2019.

    Conference Call Information
    Adverum will host a conference call and audio webcast today at 1:30 pm PT / 4:30 pm ET to report its first quarter 2020 financial results, discuss the INFINITY Phase 2 trial, and provide an update on recent business progress. The live audio webcast and accompanying slide presentation will be accessible under Events and Presentations in the Investors section of the company's website. To participate in the conference call dial 1-866-420-8347 (domestic) or 1-409-217-8241 (international) and refer to the "Adverum Biotechnologies' First Quarter 2020 Earnings Call." It is recommended call participants dial in15 minutes in advance. The archived audio webcast will be available on the Adverum website following the call and will be available for 30 days.

    About the INFINITY Phase 2 Trial of ADVM-022 in DME
    INFINITY is a Phase 2, multi-center, randomized, double-masked, active comparator-controlled trial designed to assess a single intravitreal (IVT) injection of ADVM-022 in patients with diabetic macular edema (DME), the most common cause of vision loss in patients with DR.

    The INFINITY trial will enroll approximately 33 patients and is designed to demonstrate superior control of disease activity following a single IVT injection of ADVM-022 compared to a single aflibercept injection, as measured by time to worsening of DME disease activity. Additional objectives include assessments of treatment burden, visual acuity, retinal anatomy and safety outcomes.

    Across the United States, leading retinal clinical trial sites will participate in the INFINITY trial. For additional information, please visit www.INFINITYclinicaltrial.com.

    About Diabetic Retinopathy (DR) and Diabetic Macular Edema (DME)
    Over 30 million people are impacted by diabetes in the United States. Diabetic retinopathy (DR) affects approximately one in three adults with diabetes and can put patients at risk of vision loss. DR can be diagnosed at different severity levels, and is the most common cause of blindness in working-age adults in the U.S.

    Diabetic macular edema (DME) is a vision-threatening complication of DR that can occur at any severity stage of DR. DME is characterized by retinal thickening in the area of the macula, and the risk of DME increases with the worsening of the DR severity score (DRSS). DME affects approximately 5% of people with diabetes and is the leading cause of vision loss in patients with DR.

    The current standard-of-care therapy for DME is anti-VEGF intravitreal injections. These are effective but typically require frequent and long-term injections for patients to maintain good vision. Compliance with these regimens can be difficult for patients, leading to undertreatment and vision loss. Real-world outcomes in DME with anti-VEGF therapy are meaningfully worse than in clinical trials.1

    About ADVM-022 Gene Therapy
    ADVM-022 utilizes a propriety vector capsid, AAV.7m8, carrying an aflibercept coding sequence under the control of a proprietary expression cassette. ADVM-022 is administered as a one-time intravitreal injection (IVT), designed to deliver long-term efficacy and reduce the burden of frequent anti-VEGF injections, optimize patient compliance and improve vision outcomes for patients with wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).

    In recognition of the need for new treatment options for wet AMD, the U.S. Food and Drug Administration granted Fast Track designation for ADVM-022 for the treatment of wet AMD.

    Adverum is currently evaluating ADVM-022 in the OPTIC Phase 1 clinical trial in patients with wet AMD and the INFINITY Phase 2 trial in patients with DME.

    About Adverum Biotechnologies
    Adverum Biotechnologies (NASDAQ:ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases. Adverum is advancing the clinical development of its novel gene therapy candidate, ADVM-022, as a one-time, intravitreal injection for the treatment of patients with wet age-related macular degeneration and diabetic macular edema. For more information, please visit www.adverum.com.

    Forward-looking Statements

    Statements contained in this press release regarding events or results that may occur in the future are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to statements regarding: the potential for ADVM-022 in treating patients with wet AMD and DME; Adverum's expectations as to its plans to advance ADVM-022 in DME by beginning to enroll patients in the INFINITY trial and the expected enrollment numbers; Adverum's expectations that its current cash position will fund its operations into 2022; and Adverum's expectations that it will present data from all four cohorts of the OPTIC Phase 1 trial for ADVM-022 in wet AMD by the end of this year.  All of these statements are based on certain assumptions made by Adverum on current conditions, expected future developments and other factors Adverum believes are appropriate in the circumstances. Adverum may not achieve any of these in a timely manner, or at all, or otherwise carry out the intentions or meet the expectations disclosed in its forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include risks inherent to, without limitation: Adverum's novel technology, which makes it difficult to predict the time and cost of product candidate development and obtaining regulatory approval; the results of early clinical trials not always being predictive of future results; the potential for future complications or side effects in connection with use of ADVM-022; obtaining regulatory approval for gene therapy product candidates; enrolling patients in clinical trials; reliance on third parties for conducting the OPTIC and INFINITY trials and vector production; the effects of the COVID-19 pandemic on the company's operations and on the company's ongoing clinical trials; and ability to fund operations through completion of the OPTIC and INFINITY trials and thereafter. Risks and uncertainties facing Adverum are described more fully in Adverum's Form 10-Q filed with the SEC on May 28, 2020 under the heading "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. Adverum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor and Media Inquiries:

    Investors:
    Myesha Lacy
    Adverum Biotechnologies, Inc.

    1-650-304-3892

    Media:
    Cherilyn Cecchini, M.D.
    LifeSci Communications

    1-646-876-5196

    _________

    1  TA Ciulla, et al. Diabetes Care 2003 Sep; 26(9): 2653-2664.

     
    Adverum Biotechnologies, Inc.
    Consolidated Balance Sheets
    (In thousands)
             
        March 31,   December 31,
          2020       2019  
        (Unaudited)     (1)  
    Assets                
    Current assets:                
    Cash and cash equivalents   $ 130,162     $ 65,897  
    Short-term investments     166,904       100,138  
    Prepaid expenses and other current assets     3,382       9,835  
    Total current assets     300,448       175,870  
    Operating lease right-of-use asset     20,406       20,963  
    Property and equipment, net     26,727       24,884  
    Restricted cash     999       999  
    Deposit and other long-term assets     19       11  
    Total assets   $ 348,599     $ 222,727  
    Liabilities and stockholders' equity                
    Current liabilities:                
    Accounts payable   $ 4,663     $ 4,103  
    Accrued expenses and other current liabilities     8,079       11,271  
    Lease liability, current portion     4,025       4,034  
    Total current liabilities     16,767       19,408  
    Lease liability, net of current portion     27,753       28,214  
    Other noncurrent liabilities     126       148  
    Total liabilities     44,646       47,770  
    Stockholders' equity:                
    Common stock     8       7  
    Additional paid-in capital     712,713       560,704  
    Accumulated other comprehensive loss     (833 )     (725 )
    Accumulated deficit     (407,935 )     (385,029 )
    Total stockholders' equity     303,953       174,957  
    Total liabilities and stockholders' equity   $ 348,599     $ 222,727  
                     
    (1) Derived from Adverum's annual audited consolidated financial statements.


     
    Adverum Biotechnologies, Inc.
    Consolidated Statements of Operations
    (In thousands except per share data)
    (Unaudited)
             
        Three Months Ended
    March 31,
          2020       2019  
                     
    Operating expenses:                
    Research and development     14,751       10,131  
    General and administrative     9,040       5,576  
    Total operating expenses     23,791       15,707  
    Operating loss     (23,791 )     (15,707 )
    Other income, net     885       1,218  
    Net loss     (22,906 )     (14,489 )
    Net loss per share — basic and diluted   $ (0.31 )   $ (0.23 )
    Weighted-average common shares outstanding - basic and diluted     73,797       63,125  
                     

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  5. REDWOOD CITY, Calif., May 21, 2020 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced that it will host a conference call and audio webcast on Thursday, May 28, 2020 at 1:30 pm PT / 4:30 pm ET to report its first quarter 2020 financial results and provide an update on recent business progress.

    The live audio webcast will be accessible under Events and Presentations in the Investors section of the company's website. To participate in the conference call, dial 1-866-420-8347 (domestic) or 1-409-217-8241 (international) and refer to the "Adverum Biotechnologies' First Quarter 2020 Earnings Call." It is recommended call…

    REDWOOD CITY, Calif., May 21, 2020 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced that it will host a conference call and audio webcast on Thursday, May 28, 2020 at 1:30 pm PT / 4:30 pm ET to report its first quarter 2020 financial results and provide an update on recent business progress.

    The live audio webcast will be accessible under Events and Presentations in the Investors section of the company's website. To participate in the conference call, dial 1-866-420-8347 (domestic) or 1-409-217-8241 (international) and refer to the "Adverum Biotechnologies' First Quarter 2020 Earnings Call." It is recommended call participants dial in 15 minutes in advance. The archived audio webcast will be available on the Adverum website following the call and will be available for 30 days.

    About Adverum Biotechnologies
    Adverum Biotechnologies (NASDAQ:ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases. Adverum is evaluating its novel gene therapy candidate, ADVM-022, as a one-time, intravitreal injection for the treatment of its lead indication, wet age-related macular degeneration. For more information, please visit www.adverum.com.

    Investor and Media Inquiries:
    
    Investors:
    Myesha Lacy
    Adverum Biotechnologies, Inc.
    
    1-650-649-1257
    
    Media:
    Cherilyn Cecchini, M.D.
    LifeSci Communications
    
    1-646-876-5196

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